Review decisions
Showing 270 results of 688 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00624
… with progressive metastatic castration-resistant prostate cancer (mCRPC), for whom prostate-specific membrane antigen … tomography of PSMA-positive lesions in men with prostate cancer: with suspected metastasis who are suitable for … antigen (PSMA)-positive lesions in men with prostate cancer: with suspected metastasis who are suitable for …
Product Type: Drug
Control Number: 242332
DIN(s): 02531836
Manufacturer: Telix Pharmaceuticals (US), Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-12-06
Issued / Original Publication Date: 2023-02-03
Decision / Authorization Date: 2022-10-13
Updated Date: 2025-02-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00560
… with non-Hodgkin lymphoma. Diffuse-large B-cell lymphoma, a cancer that starts in a type of white blood cells called B … Orbis , an international partnership designed to give cancer patients faster access to promising treatments. The …
Product Type: Drug
Control Number: 247025
DIN(s): 02518627
Manufacturer: Incyte Corporation
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2020-12-04
Issued / Original Publication Date: 2021-11-25
Decision / Authorization Date: 2021-08-19
Updated Date: 2025-05-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00522
… heart disease, chronic kidney disease, type 2 diabetes, cancer, and, pulmonary obstructive disease. Care for …
Product Type: Drug
Control Number: 246758
DIN(s): 02513153
Manufacturer: Janssen Inc.
Submission Type: Application for authorization under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19
Date Filed / Submission Date: 2020-11-30
Issued / Original Publication Date: 2021-03-19
Decision / Authorization Date: 2021-03-05
Updated Date: 2024-01-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00561
… They account for approximately 15% of all primary liver cancers and approximately 3% of gastrointestinal … is increasing and approximately 2% of all annual cancer-related deaths are due to these malignancies. Fusions … project is an international partnership designed to give cancer patients faster access to promising cancer …
Product Type: Drug
Control Number: 246904
Manufacturer: QED Therapeutics, Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2020-11-30
Issued / Original Publication Date: 2021-11-30
Decision / Authorization Date: 2021-09-27
Updated Date: 2025-06-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00812
… the submission was to seek market authorization for the BC Cancer Agency (BCCA) Sodium Pertechnetate ( 99m Tc … Regulations Date of decision: 2020-11-26 Manufacturer: BC Cancer, Part of the ProvInc.ial Health Services Authority …
Product Type: Drug
Control Number: 231915
DIN(s): 02508230
Manufacturer: BC Cancer, Part of the ProvInc.ial Health Services Authority
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-12-16
Decision / Authorization Date: 2020-11-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00841
… therapy of hypothyroidism and TSH suppression in thyroid cancer through a multitude of studies. This New Drug … treatment of hypothyroidism and TSH suppression in thyroid cancer. The benefit-risk ratio for the treatment of subacute …
Product Type: Drug
Control Number: 232047
DIN(s): 02508486, 02508494, 02508508, 02508516, 02508524, 02508532, 02508540, 02508559, 02508567, 02508575, 02508583, 02508591
Manufacturer: Ibsa Institut Biochimique SA
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-09-27
Decision / Authorization Date: 2020-11-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00722
… for the treatment of metastatic Non-Small Cell Lung Cancer (NSCLC) with no Epidermal Growth Factor Receptor …
Product Type: Drug
Control Number: 234228
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-12-06
Decision / Authorization Date: 2020-11-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00563
… Kymriah, Yescarta, Carvykti related to T-cell malignancy (cancer that forms in white blood cells called T cells). Drug … T-cell immunotherapy that binds to CD19-expressing cancer cells and normal B cells. Studies demonstrated that …
Product Type: Drug
Control Number: 246355
DIN(s): 02516667, 02532719
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2020-11-13
Issued / Original Publication Date: 2021-12-06
Decision / Authorization Date: 2021-06-08
Updated Date: 2025-03-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00575
… reported rates of malignancies excluding non-melanoma skin cancers (0.7% vs. 0.6%) and malignant neoplasms including non-melanoma skin cancers (1.2% vs. 0.6%) did not differ between the treatment …
Product Type: Drug
Control Number: 246187
DIN(s): 02522845
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-11-09
Issued / Original Publication Date: 2022-02-08
Decision / Authorization Date: 2021-11-30
Updated Date: 2025-10-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00595
… project is an international partnership designed to give cancer patients faster access to promising cancer treatments. The NDS for Rholistiq was classified as a …
Product Type: Drug
Control Number: 245791
DIN(s): 02526115
Manufacturer: Kadmon Pharmaceuticals LLC
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2020-11-03
Issued / Original Publication Date: 2022-07-07
Decision / Authorization Date: 2022-03-23
Updated Date: 2025-06-19